Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36036—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of the outer, middle or inner ear
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/02—Details
  • A61N1/04—Electrodes
  • A61N1/0404—Electrodes for external use
  • A61N1/0408—Use-related aspects
  • A61N1/0456—Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/3603—Control systems
  • A61N1/36031—Control systems using physiological parameters for adjustment
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/36021—External stimulators, e.g. with patch electrodes for treatment of pain
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
  • A61N1/00—Electrotherapy; Circuits therefor
  • A61N1/18—Applying electric currents by contact electrodes
  • A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
  • A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
  • A61N1/36014—External stimulators, e.g. with patch electrodes
  • A61N1/36025—External stimulators, e.g. with patch electrodes for treating a mental or cerebral condition

Definitions

• the invention relates to a system, a device and a method for treating the diseases and/or disorders by way of stimulation of the auricular vagus nerve by intermittent direct current.
• the autonomic nervous system is a system controlling all of the vital functions of the body. In other words, all of the functions of our organs that are not able to be controlled by our are managed by the autonomic nervous system.
• the activity of the autonomic nervous system varies during the daily life, serving to enable our body to accommodate the changes in the internal and external environment.
• the impairments in the variable activity of the autonomic nervous system lead to the impairment in the body's ability to adapt to the variables in the internal and external environment, resulting in the emergence of the autonomic dysfunction and the associated diseases.
• Activation of the nerves via stimulation is employed for the treatment of the resulting disorders and diseases.
• the nerves may be stimulated by sending electrical signals to various nerves from various parts.
• the stimulation is realized via different parts of different nerves by means of the signals of different electrical property for treating different disorders.
• the properties of the stimulation signal to be sent vary according to the disorder intended to be treated, not every stimulation exhibits the same effect in every patient. Accordingly, it is of great importance to be able to determine the correct current parameters for improving the efficacy and safety of the treatment.
• Various biofeedback systems are utilized for the identification of the correct current parameters.
• different effects are attempted to be obtained by varying the current parameters such as frequency, pulse width, waveform and the like, the vagus nerve is always stimulated via biphasic current.
• US2020179689A1 discloses a system and a method developed for the treatment of migraine attacks. According to the said system, the electrodes are attached to the forehead of a patient and the stimulation of the trigeminal nerve is provided via the electric signals for the purpose of treating the migraine attacks.
• US2015142082 similarly aims at treating a disorder via the electrical stimulation of the nerve.
• the said system differs in that it comprises a biological feedback mechanism.
• the physiological outputs of the patient are measured to determine their responses to said stimulation.
• Said physiological output may be a value such as the pulse variability, electrocardiogram, blood flow and finger temperature. Said values are measured with the help of various sensors and the electrical signals sent for stimulating the nerve are revised in line with the measured values.
• Stimulation of the vagus nerve via biphasic current causes an increase in the nerve activity.
• the hyperactivity of parasympathetic nervous system and vagus is observed in case of hypersomnia, allergy and some similar diseases, and it is required to reduce this hyperactivity.
• side effects may develop in the individuals as a result of hyperstimulation of the vagus nerve and it is required to suppress the vagus nerve, even if for a short time.
• An object of the invention is to develop a system and a method wherein the treatment of diseases and/or disorders is provided by the stimulation of the vagus nerve.
• Another object of the invention is to develop a system and a method wherein the treatment of diseases and/or disorders is provided by the stimulation of the vagus nerve by an intermittent direct current.
• Another object of the invention is to develop a system and a method wherein the treatment of diseases and/or disorders is provided by the stimulation of the vagus nerve via the ear.
• Another object of the invention is to develop a system and a method wherein it is possible to set the electrodes such that they will exhibit polarity as an anode as well as a cathode depending on preference and thus it is possible to stimulate the vagus nerve in an opposite manner.
• Figure 1 A side view of the stimulator and the earpiece
• Figure 2 A rear view of the stimulator and the earpiece
• Figure 3 A front view of the stimulator
• Figure 4 A view of the earpiece
• FIG. 5 A view of the stimulator
• Figure 6 A graph showing the stimulation with intermittent direct current Reference Numerals
• the invention relates to a method, a system and a device for treating the diseases and/or disorders by way of stimulation of the auricular vagus nerve by intermittent direct current. More particularly, the invention relates to a method, a system and a device wherein the stimulation may be performed in a controlled manner by providing intermittent direct current to at least one of, preferably both, vagus nerves in the ears.
• Auricular vagus nerve electrical stimulation is a developing technology for the therapeutic practices in the field of bioelectronic medicine.
• the modulation of the afferent vagus nerve affects a great number of physiological processes and physical conditions associated with the transfer of information between the brain and the body.
• This method has treatment-enhancing effects for various diseases such as chronic pain, neurodegenerative and metabolic disorders, inflammatory and cardiovascular diseases (Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Sarolic A, Lechner S, Klonowski W, Varoneckas G, Szeles JC. Current Directions in the Auricular Vagus Nerve Stimulation I - A Physiological Perspective. Front Neurosci. 2019 Aug 9; 13: 854).
• the fibers may be locally overstimulated and understimulated during the vagus nerve stimulation.
• the needle electrodes typically act as polarizable electrodes for the percutaneous vagus nerve simulation (VNS)
• the surface electrodes may serve as non- polarizable electrodes for transcutaneous aVNS.
• Monopolar aVNS offers the most diffuse stimulation with the lowest stimulation threshold.
• Monophasic stimulation leads to depolarization or hyperpolarization in an exposed terminal near the electrode or at a location of bending (Kaniusas E, Kampusch S, Tittgemeyer M, Panetsos F, Gines RF, Papa M, Kiss A, Podesser B, Cassara AM, Tanghe E, Samoudi AM, Tarnaud T, Joseph W, Marozas V, Lukosevicius A, Istuk N, Lechner S, Klonowski W, Varoneckas G, Szeles JC, Sarolic A. Current Directions in the Auricular Vagus Nerve Stimulation II - An Engineering Perspective. Front Neurosci. 2019 Jul 24; 13: 772).
• Direct Current Stimulation alters neuronal input/output function. Brain Stimul. 2017; 10(1): 36-45).
• the intermittent direct current may be preferable for transcranial stimulation and may affect the autonomic nervous system activity (Leon Morales-Quezada, Camila Cosmo, Sandra Carvalho, Jorge Leite, Laura Castillo-Saavedra, Joanna R. Rozisky, Felipe Fregni. Cognitive effects and autonomic responses to transcranial pulsed current stimulation. Exp Brain Res (2015) 233: 701-709).
• the electrode polarity could influence the autonomic nervous system activity in a different way (Brunoni AR, Vanderhasselt MA, Boggio PS, Fregni F, Dantas EM, Mill JG, Lotufo PA, Bensenor IM. Polarity- and valence-dependent effects of prefrontal transcranial direct current stimulation on heart rate variability and salivary cortisol. Psychoneuroendocrinology. 2013 Jan; 38(1): 58-66). Reversing the polarity of the stimulation usually causes opposite effects on the transcranial direct current stimulation, but this is not always the case (Das S, Holland P, Frens MA, Donchin O. Impact of Transcranial Direct Current Stimulation (tDCS) on Neuronal Functions. Front Neurosci. 2016 Nov 30; 10: 550).
• tDCS Transcranial Direct Current Stimulation
• Auricular vagus nerve stimulation sends the signals first to the solitary tract nucleus in the brain stem. Therefore, it may be considered or accepted as a cranial neuromodulation method.
• the direct current stimulation has a long-lasting effect on H-reflex by modulating the excitability of sensory and motor fibers in the human posterior tibial nerve.
• Cathodal direct current stimulation (DCS) considerably increases the H-reflex and M-wave amplitude; on the contrary, anodal direct current stimulation considerably reduces the amplitudes.
• the effect of the direct current stimulation may continue also after it is terminated. However, this condition lasts longer in the H-reflex as compared to the M-wave.
• Bastos et al. investigated how the distance between the electrodes affects the spatial distribution of the electric field in the lumbar and sacral spinal cord during the transcutaneous spinal direct current stimulation. Increasing the inter-electrode distance results in a wider electric field distribution with greater maximum peak values and a smoother variation along the spinal cord. The results indicate that the choice of the position of the return electrode relative to the target could affect the electric field size distribution and value interval (Bastos R, Fernandes SR, Salvador R, Wenger C, de Carvalho MA, Miranda PC. The Effect of InterElectrode Distance on the Electric Field Distribution during Transcutaneous Lumbar Spinal Cord Direct Current Stimulation. ConfProc IEEE EngMedBiolSoc. 2016 Aug; 2016: 1754-1757).
• the electrodes are arranged such that one is positioned in the ear and the other with an opposite pole is positioned distally in the neck.
• Most of the nerve fibers in the external ear extend from the cervical region.
• the greater auricular nerve located in the inferior and posterior sections of the auricle is a superficial branch of cervical plexus contributed by the fibers extending from C2 and C3 spinal nerves (Butt MF, Albusoda A, Farmer AD, Aziz Q. The anatomical basis for transcutaneous auricular vagus nerve stimulation. J Anat. 2020 Apr; 236(4): 588-611).
• the greater auricular nerve is located adjacent to the vagus nerve and a part of the fibers are intertwined. Positioning the opposite electrode longitudinally, especially in the C2-C3 dermatomes, may create an additional effect for the vagus nerve stimulation due to such proximity. Owing to this proximity, the electrical loop may be completed easily.
• the current will be sensed or started to be sensed first in the ear. This will allow the current intensity to be adjusted via the vagus nerve dermatome. Since the primary aim is to correctly stimulate the vagus nerve and thereby regulate the autonomic nervous system activity, the electrode surfaces in the neck will be preferably greater than those of the electrodes in the ear.
• the system and device according to the invention comprise in their most basic form at least one electrode enabling to stimulate the vagus nerve and at least one stimulator (S) enabling to conduct electric current to the electrode.
• a preferred embodiment of the invention comprises at least two electrodes.
• at least one of the electrodes sends signal to an area where the auricular vagus nerve is present and another electrode sends signal to an area outside the vagus nerve.
• at least one of the electrodes is located in the ear and another electrode is located in the nape.
• the nape electrode (21) is shown in Figure 2 and Figure 3, and the ear electrode is shown in Figure 4.
• the nape electrode (21) is positioned in a quantity of at least two, one on the right ear side and the other on the left ear side, as can be seen in Figure 2 and Figure 3.
• the ear electrodes are present in a total quantity of four, i.e. two electrodes, namely the concha ear electrode (22) and tragus ear electrode (23), in each ear.
• the concha ear electrode (22) and tragus ear electrode (23) may be active.
• the electrode required to perform the stimulation has a surface area that contacts the skin surface or beneath the skin surface and has a transmission energy field for an effective treatment within the safety limits according to the current intensity.
• the electrical connection of the stimulator (2) ( Figure 5) with the patient may be ohmic or capacitive.
• the cable output portion (63) where said cable output (5) is present has a relatively elastic structure.
• the body end portion (61) and the body middle portion (62) containing the stimulator (S) parts like battery and electronic card are manufactured from a more rigid plastic material.
• At least one visual warning member (8) indicating the status of the device is present on the stimulator (S).
• the parts of the device such as battery and electronic card are positioned in the body middle portion (62).
• the elastic piece (1) which enables the device to remain fixed in the user's ear, extends around the earlap to enable the electrodes to remain stable.
• the device additionally comprises at least one signal generator generating the signal to be sent from the electrodes, a power supply connected to the generator, and a control unit connected to the former two.
• the device comprises at least one sensor (3), which enables feedbacks to be obtained from the patient following the stimulation. According to the feedbacks obtained via said sensor (3) from the patient, it is possible to alter the polarity of the electrodes as well as other stimulation parameters. While the sensor (3) is not in contact with the skin when the device is in the off state, it is able to contact the skin by extending between the electrodes by means of a spring system when the device is turned on.
• the device comprises the sensors (3) such that there is at least one sensor in each ear.
• An intermittent direct current is supplied to the electrodes by the stimulator (S).
• the pulse duration varies between 40 ps and 150 ps.
• the inter-pulse interval of the current varies between 50 ps and 1 s.
• the frequency is a value varying between 1 Hz and 1000 Hz.
• the current intensity may be adjusted up to 4 mA with a precision of 0,1 mA.
• the dimensions, more specifically the surface areas, of the electrodes positioned in the ear and the nape are different from each other.
• the surface area of the nape electrode (21) positioned in the nape may adjusted such that it will be greater than the surface area of the tragus ear electrode (23) or the concha ear electrode (22). Having a greater electrode surface area in the neck region enables the amplitude adjustment to be made according to the vagus.
• the current intensity per unit area and the individual's extent of sensation of the current decrease. Since the primary objective is to stimulate the vagus nerve in the ear, the current intensity is adjusted according to the current sensation in the ear.
• the surface areas of the electrodes i.e. the surface areas of the tragus ear electrode (23) and the concha ear electrode (22) and the nape electrode (21), are the same.
• one of the ear electrodes i.e. one of the tragus ear electrode (23) or the concha ear electrode (22) becomes active.
• the system may automatically decide which electrode will be active, before the start of stimulation or during the stimulation, or, the active electrode may be selected by the user. Since the distribution of the vagus nerve in the ear may exhibit variation among the individuals, the tragus or concha stimulation may yield different responses among the individuals. That the ear electrode (tragus or concha) is selectable makes it possible for the stimulation to become more effective.
• the electrodes may be set as anode or cathode.
• which electrode will act as an anode and which electrode will act as a cathode may be set. It is possible to separately assess the polarity of the electrodes and alter the same independently of one another. The current direction changes and different stimulations are obtained depending on the alteration of the polarity of the electrodes. Since altering the current direction alters the neuronal polarization/depolarization, an extra ability of control is provided on the nerve activity. Operation of said electrodes as anode or cathode is controlled by the stimulator (S).
• the nape electrodes (21) have an adhesive character. In this way, the weight of the stimulator (S) may be borne partially also by these electrodes.
• the stimulator (S) is controlled via a smart device.
• the smart device is a mobile phone and is capable of wirelessly communicating with the stimulator (S).
• the sensor (3) or sensors (3) used within the scope of the invention may measure the personal values like the pulse, pulse variability, body temperature, skin resistivity, and evoked potential from any part of the body outside the ears; or, in addition to these measurements, they may measure like the ear secretion pH and the liquid, electrolyte and fat contents of the ear secretion from the ears, via a smart wristband, mobile phone application.
• the right and left side intermittent direct current stimulation will be adjusted independently. While the current may be supplied simultaneously to both sides, it is also possible that the current is supplied only to the right side or the left side. Or, the stimulation may be applied alternately, i.e. may be applied to the right ear for a certain time and to the left ear for a certain time.
• the system may decide which of the electrodes will be active and which of the electrodes will be passive, or the user may make the decision in this regard in the beginning, and the system may switch the active electrode into the passive state or the passive electrode into the active state during the application.
• the system may decide which of the electrodes in one ear (the tragus ear electrode (23) or the concha ear electrode (22)) will be active or the operator may make this selection by their will in the beginning.
• the system may make changes regarding the active state between the ear electrodes during the application. In other words, the currently active electrode may switch into the passive state and the currently passive electrode may switch into the active state. While the tragus ear electrode (23) may be active in one ear, the concha ear electrode (22) may be active in the other ear.
• the system decides which one of the electrodes will be positive and which one will be negative according to the data received from the sensors (3).
• the electrode (tragus or concha) in one ear may be in the positive pole, while the electrode (tragus or concha) in the other ear may be in the negative pole.
• the system may alter the other stimulation parameters such as waveform, duration, phase, intensity, frequency and pulse width according to the data received from the sensors (3).
• An exemplary mode of operation for the device and system according to the invention may be as follows:
• the intermittent direct current stimulation is initiated by the stimulator (S) such that the left ear concha ear electrode (22) is positive, the left side nape electrode (21) is negative, the right ear concha ear electrode (22) is positive, and the right side nape electrode (21) is negative.
• the electrode polarities on the left side are changed such that the concha ear electrode (22) will be negative and the nape electrode (21) will be positive. No change is made on the right side.
• the frequency value of the current supplied to the left side is increased, the right side concha ear electrode (22) is disabled and the tragus ear electrode (23) is activated, again based on the information received from the sensors (3).
• the system may continue the stimulation applied until that moment, without making any change, or may send a signal to the user, or may automatically terminate the stimulation.
• the disclosed procedure is intended to exemplify the method of operation according to the invention and is not limiting.
• the system may alter the electrode polarities or electrode activities (tragus or concha), i.e. the system may alter the active or passive state of the tragus ear electrode (23) or the concha ear electrode (22).
• the system may, in addition to the electrode polarity change or active electrode changes, i.e. alteration of the active or passive state of the electrodes, also alter the stimulation parameters such as waveform, duration, phase, intensity, frequency, pulse width and inter-pulse interval, etc.

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Citations (6)

• 2020
  • 2020-12-30 TR TR2020/22374A patent/TR202022374A1/tr unknown
• 2021
  • 2021-06-14 WO PCT/TR2021/050576 patent/WO2022146294A1/en active Application Filing

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